Job Reference: FRS49626
Job Duration:
Start date:
Description:
Due to ongoing expansion my client, leading medical device manufacturing company are recruiting Quality Manager - Multi Site to join their team in Limerick.
Reporting directly to the Quality Director, you will be responsible for the compliance/certifications, complaints/corrective actions, and for the financial aspect of the quality function for 3 sites. 1 in Limerick which is recognised as the centre of excellence within thecompany and 2 further sites in the US. You will have 2 knowledgeable Quality Engineers at each site reporting into you.
ThePosition…
* Generous salary and benefits package on offer, including company car.
* Fantastic opportunity to join aleading company who have invested heavily into their Limerick facility.
* Friendly environment coupled with strong work ethic, good systems and career progression opportunities.
* Travel up to 30% to US sites and customer sites.
Responsibilities:(A Snapshot…)
* Customer-Facing Metrics (CFM) - Drive actions to improve performance to CFMs
* On-Time Delivery -Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement.
* Compliance/Certification
* Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including assignment of primary contacts and coordinating training support.
* Ensure Management reviews are conducted to provide for systems review.
* Manage Internal Audit Program.
* New/Change Product/Process Validation
* Oversee management of Validation activities
* Ensure appropriate protocols are written, identified actions are completed, inclusive reports are written.
* Management of Implementation and Documentation of IQ, OQ, PQ
* Ensure timely and conclusive validations, including validation reports.
Requirements:
* Bachelor's Degree Business Administration, Engineering or related field required, certification to internal auditing preferred.
* 5-7 years Quality Management experience, with multi-site experience (with global cultural awareness), preferably in medical device, required.
* Strong P&L Leadership, financial acumen* Experience driving zero PPM in a lean manufacturing environment Knowledge/experience with ISO 13485 and 21 CFR 820, or equivalent, quality system requirements required.
* Ability to use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab® (or other statistics software).
* Ability to build respect/trust within internal staff/other functional leaders as well as external customers.
* Excellent interpersonal, communication (verbal and non-verbal), andpresentation skills.
* Possesses excellent time management, prioritization abilities, and strong project management skills.* Highly motivated, detail-oriented, and eager to drive needed change.
* Demonstrated ability to autonomously make strategic decisions.
* Must possess comprehension and reasoning skills used to understand and collect data, interpret technical instructions, and draw valid conclusions.
* Ability to apply advanced mathematical concepts and theory such as geometry, statistics, algebra, calculus, and differential equations to address engineering issues.
* Demonstrated ability to analyse data and make sound, enterprise-first, problem-solving decisions.
* Ability to travel occasionally to other company locations and for customervisits.
Next Steps:
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Industry: Manufacturing and Production
Salary:
Salary Benefits:
Vacancy Type: Permanent
Job Skills: Quality manager, ISO 13485, medical device manufacturing
Contact Name: Kerry Rickard
Website: -
Direct Application URL: -